RO7771950 vs Tucatinib for Breast Cancer

(BREnnA Trial)

Recruiting at 3 trial locations

Overseen By Reference Study ID Number: WO46069 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Hoffmann-La Roche

Must be taking: Anti-HER2 therapy

Must not be taking: CYP3A4/CYP2C8 inhibitors/inducers

Disqualifiers: Cardiovascular disease, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 35 months

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, RO7771950 (an experimental treatment), combined with two other drugs, compared to the existing treatment, tucatinib, for breast cancer. It targets individuals with advanced or metastatic HER2-positive breast cancer, characterized by a protein that promotes growth. Participants should have received at least one anti-HER2 therapy and may have stable or progressing brain metastases. The trial aims to determine which treatment combination works best for such patients. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering a promising opportunity to advance breast cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any drugs or herbal medicines that strongly affect certain liver enzymes (CYP3A4 or CYP2C8) or oral anticoagulants like warfarin. If you're on these, you might need to stop or switch medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research has studied RO7771950 for its safety in treating breast cancer. Although specific safety details from these studies are not provided, comparing it to a well-known treatment like tucatinib suggests some confidence in its safety.

Research shows that tucatinib is generally well-tolerated when combined with trastuzumab and capecitabine. Common side effects include diarrhea, hand-foot syndrome, and nausea. Despite these side effects, the treatment has proven effective for patients with HER2-positive breast cancer, improving outcomes and survival rates.

Both treatments are undergoing advanced clinical trials, indicating a reasonable level of safety in earlier stages. Prospective participants should discuss potential side effects and personal health considerations with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

RO7771950 is unique because it offers a novel approach to treating breast cancer by specifically targeting cancer cells with a new mechanism of action. Unlike standard treatments, which often include chemotherapy drugs like capecitabine and targeted therapies like trastuzumab, RO7771950 may provide a more tailored attack on cancer cells, potentially leading to better outcomes. Researchers are particularly excited about RO7771950's potential to improve effectiveness while possibly reducing side effects typically associated with more generalized cancer treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare RO7771950 and Tucatinib for treating HER2-positive breast cancer. Studies have shown that tucatinib effectively treats this type of cancer, reducing the risk of death by 34% compared to some other treatments. Patients taking tucatinib with other drugs lived longer, with an average survival time of 21.9 months. Another study found that combining tucatinib with trastuzumab and capecitabine extended survival, even for patients with cancer that had spread to the brain.

Participants in this trial may receive RO7771950, which remains under investigation. Early results suggest it might be effective because it targets the HER2 protein, which promotes cancer cell growth. More research is needed to fully understand its effectiveness compared to tucatinib. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with HER2-positive breast cancer that has spread locally or to other parts of the body. Participants must have had at least one prior anti-HER2 treatment, good organ function, and be able to carry out daily activities. People with certain previous treatments may not qualify.

Inclusion Criteria

My organ and bone marrow function meet the study's requirements.

I am fully active or restricted in physically strenuous activity only.

I have received at least one anti-HER2 treatment for advanced or metastatic cancer.

Exclusion Criteria

I have not had any cancer treatment or trial drugs in the past 28 days.

I have active or untreated hepatitis B, hepatitis C, or chronic liver disease.

I have serious heart problems or high risk for heart-related issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7771950 or Tucatinib in combination with trastuzumab and capecitabine

Approximately 35 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• RO7771950
• Trastuzumab
• Tucatinib

Trial Overview

The study compares two combinations: RO7771950 plus trastuzumab and capecitabine versus tucatinib plus trastuzumab and capecitabine. Patients are randomly assigned to either group to see which works better and is safer.

How Is the Trial Designed?

Group I: Arm B - RO7771950 Dose Type 2 Experimental Treatment 3 Interventions

Group II: Arm A - RO7771950 Dose Type 1 Experimental Treatment 3 Interventions

Group III: Arm C - Tucatinib Active Control 3 Interventions

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07413939

Study Details | NCT07413939 | RO7771950 Versus ...

The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in ...

2.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07413939

RO7771950 Versus Tucatinib in Combination With ...

Outcome Measure, Measure Description, Time Frame. Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12474727/

Real-world treatment patterns and clinical outcomes ... - PMC

To describe real-world characteristics and clinical outcomes among patients with HER2+ MBC receiving tucatinib-based treatments.

4.

clinicaltrials.eu

clinicaltrials.eu/trial/comparing-ro7771950-with-a-drug-combination-of-tucatinib-trastuzumab-and-capecitabine-in-patients-with-her2-positive-metastatic-or-locally-advanced-breast-cancer/

Comparing RO7771950 with a drug combination of ...

This study involves patients with HER2-positive breast cancer, a type of cancer where cells have too much of a certain protein that helps them grow.

5.

ctv.veeva.com

ctv.veeva.com/study/ro7771950-versus-tucatinib-in-combination-with-trastuzumab-and-capecitabine-in-people-with-locally-a

RO7771950 Versus Tucatinib in Combination With ...

The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12836521/

Real-world safety and effectiveness data of trastuzumab ...

In patients with TNBC receiving SG, the 12-month PFS rate was 16.2 (IQR 8.1-32.4), whereas in patients with HR-positive/HER2-negative mBC, it was 23.6 (IQR 13.8 ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/61588f40ea9645b28993acea59a2d0ba

RO7771950 - Drug Targets, Indications, Patents

HER2 Positive Breast CancerLocally advanced breast cancerNeoplasm Metastasis ... Clinical Results associated with RO7771950. Login to view ...